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Xarelto gains NICE thumbs up for DVT licence

UK News | April 22, 2013


Ben Adams

Xarelto gains NICE thumbs up for DVT licence

NICE has given a provisional green light for Bayer’s blood thinner Xarelto for help patients with thrombotic events.

The Institute has issued final draft guidance recommending Bayer and Janssen’s Xarelto (rivaroxaban) pill for treating pulmonary embolism (PE) and preventing recurrent deep vein thrombosis (DVT) and PE after acute PE in adults. NICE had initially been unconvinced of the drug for this licence, but has now received extra information from Bayer, allowing the recommendation.

Xarelto costs £2.10 per 15mg or 20mg tablet, and the cost of treatment is estimated to be £235.86, £427.61 and £811.13 for three, six and twelve months of treatment, respectively.

With the committee’s preferred assumptions, the incremental cost for long-term treatment with the drug was under £19,400 per QALY gained, and so within the normal cost-effectiveness threshold.

Xarelto is already recommended as an option to prevent stroke in atrial fibrillation patients, and competes with Pfizer’s Eliquis and Boehringer’s Pradaxa.

Professor Carole Longson, NICE health technology evaluation centre director, said: “The committee heard from the patient expert that the regular monitoring and dose adjustment needed with warfarin, which needs regular visits to hospital or GP appointments, can be costly and inconvenient, and means some people might have to take time off work.

“Also, because warfarin has many drug interactions, it may be unsuitable for people with comorbidities. In addition, the Committee heard that warfarin has various food interactions which often require people to adjust and monitor their diet and lifestyle. Rivaroxaban therefore represents a significant potential benefit for people with PE and DVT because it avoids the need for initiation with heparin and the subsequent transition to warfarin.”

Final guidance is likely to be published in May 2013.

DVT occurs when a blood clot (thrombus) forms in the deep veins of the leg or pelvis. Blood flow through the affected vein can be limited by the clot, and it can cause swelling and pain in the leg.

If the thrombus dislodges and travels to the lungs, this can lead to a potentially fatal pulmonary embolism (PE) when the clot blocks the blood supply to the lungs.

Even if blood clots are not fatal, they can still result in long-term illness, including venous ulceration and development of a post-thrombotic limb (chronic pain, swelling and skin changes in the affected limb) and have a significant impact on quality of life.

Risk factors for DVT and PE include age over 60 years, recent surgery/serious injury, obesity, prolonged travel, acute medical illness, immobility and pregnancy. It is estimated that there will be over 50,000 cases of acute DVT in England and Wales each year by 2016, due in large part to the aging population.

People with suspected PE are generally treated immediately with drugs that help to prevent the blood from clotting (anticoagulants), most commonly with injections of low molecular weight heparin and when the diagnosis has been confirmed, an oral anticoagulant such as warfarin.

Duration of treatment is based on individual risk of recurrent DVT or PE, as well as their risk of bleeding.

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